Takeda Acquires Global Rights to Soticlestat from Ovid Therapeutics in $856 Million Deal

Compiled by Keke

On March 4, Takeda Pharmaceutical Company Limited and Ovid Therapeutics, a biopharmaceutical company specializing in rare neurological diseases, announced that they had entered into an exclusive agreement under which Takeda would acquire global rights to soticlestat (TAK-935/OV935), an investigational drug developed by Ovid for the treatment of developmental and epileptic encephalopathies. The candidate drug is being developed for indications including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Ovid’s stock price surged more than 74% in pre-market trading.

Under the new exclusive agreement, Takeda will assume full responsibility for the further global development and commercialization of soticlestat. Ovid will no longer bear any financial obligations to Takeda under the original collaboration agreement, including milestone payments or any future development and commercialization costs. The transaction is scheduled to close this month, with Ovid receiving an upfront payment of $196 million at closing and qualifying for additional payments totaling $660 million upon the achievement of development, regulatory, and sales milestones. Furthermore, Ovid will receive tiered royalties starting in the low double digits, potentially reaching up to 20% of soticlestat sales if approved and commercialized. The new agreement is expected to close by the end of March 2021, subject to customary closing conditions, including review by relevant regulatory authorities under the Hart-Scott-Rodino Act.

Soticlestat (TAK-935/OV935) is a first-in-class cholesterol 24-hydroxylase (CH24H) inhibitor with the potential to reduce seizure susceptibility and improve seizure control. By inhibiting CH24H, soticlestat lowers neuronal levels of 24-hydroxycholesterol (24HC) and may help restore the disrupted excitatory/inhibitory balance in the brain.

In August 2020, Takeda and Ovid reported positive results from the Phase 2 ELEKTRA study. This Phase 2 trial evaluated soticlestat in 141 children aged 2 to 17 years with refractory epilepsy syndromes, including Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). After 20 weeks of treatment, patients with DS receiving soticlestat experienced a mean 34% reduction in convulsive seizures, compared with a 7% increase in the placebo group, resulting in a difference of 46%. The drug’s efficacy in patients with LGS was less robust but still statistically superior to placebo. At the time, both companies stated that further analysis of the data was needed to better understand the potential next steps for soticlestat in this “highly heterogeneous patient population.” Takeda planned to initiate Phase 3 studies of soticlestat in children and young adults with DS and LGS in the second quarter of 2021.

As early as 2017, the two companies reached a cooperation agreement under which Takeda acquired an equity stake in Ovid, which became eligible to receive up to $85 million in regulatory milestone payments. Ovid demonstrated the success of conceptual trials of soticlestat in multiple rare epilepsies. The two companies divided the markets for soticlestat: Takeda secured the Japanese market and opted for commercialization rights in Asia and selected regions, while Ovid retained rights for the United States, Europe, Canada, and Israel.

Takeda introduced that soticlestat has become an important late-stage molecule in the company's portfolio, primarily targeting rare neurological and neuromuscular diseases with unmet needs. Takeda is making efforts to efficiently initiate and conduct Phase 3 studies in children and young adults with DS and LGS, aiming to launch new treatment options in the future that provide better seizure control, tolerability, and physical function for patients with DS and LGS worldwide.

As Takeda advances the development of soticlestat, Ovid will reinvest new capital into its own pipeline. This pipeline includes gaboxadol (OV101), which the company is developing for the treatment of Angelman syndrome and Fragile X syndrome. However, the Angelman syndrome program was put on hold after it missed the primary endpoint in a Phase 3 study in December 2020.

References:

1.After farming an epilepsy med out to Ovid, Takeda brings it back into the fold

2.Takeda Secures Global Rights from Ovid Therapeutics to Develop and Commercialize Soticlestat for the Treatment of Children and Adults with Dravet Syndrome and Lennox-Gastaut Syndrome